The Impact of Prehabilitation

NCT ID: NCT06181253

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2026-03-31

Brief Summary

While numerous studies have assessed the promising impacts of prehabilitation, there is a lack of prehabilitation research within lower socioeconomic patient populations. Often for prehabilitation studies, patients are heavily involved in full scale exercise and nutrition programs weeks before the scheduled procedure. In underserved populations, programs such as these are often not feasible due to lack of transport, resources, and other barriers to healthcare. The investigators seek to evaluate the effectiveness of inexpensive interventions in lower socioeconomic populations.

The investigators hypothesize that barriers to prehabilitation are environmental and that prehabilitation interventions tailored for lower socioeconomic (SES) populations will improve time to discharge, mobility, and in turn, readmission rates.

The participants for this clinical trial will be seen four times: initially at the preoperative surgical clinic (6-8 weeks prior to surgery), 1-2 days preop at a pre-procedure clinic, postoperative in the inpatient setting (as soon as the participant is able to ambulate during their hospital stay), and in the postoperative surgical clinic at the postoperative visit. Patients will be within the general surgery, colorectal, and surgical oncology departments at Boston Medical Center (BMC).

The anticipated sample size is 60 participants (30 in the intervention/prehabilitation arm and 30 in the control/usual care arm). Participants in the intervention arm will participate in a mobility and step tracking intervention aimed at improving postoperative outcomes. The control group will follow routine standard of care at BMC for preoperative and postoperative care.

Conditions

Post Operative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prehabilitation group

Watch a video created by the investigators, discussing exercise prior to surgery, receive text message reminders to begin exercise before surgery, and take walking tests before and after surgery.

Group Type: EXPERIMENTAL

Preoperative education

Intervention Type: OTHER

The intervention will be an instructional video describing proper walking technique particularly up flights of stairs for patients to do at home. This will be shown at preoperative surgical clinic and will be available for access at home from patient's cell phones. The video is currently in production at BMC. Additionally, text reminders will be sent daily to remind patients to walk at home.

Moderate aerobic exercise

Intervention Type: BEHAVIORAL

Participants will be encouraged to compete 140-150 minutes of moderate aerobic exercise per week- achieved by two walking sessions per day 10-11 minutes in length (realistic/achievable goal)

Text messages

Intervention Type: OTHER

Text reminders will be sent daily to remind patients to walk at home.

Pedometer

Intervention Type: BEHAVIORAL

Participants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer

Control group

Receive the usual preoperative and post operative care and they will be provided a pedometer.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Preoperative education

The intervention will be an instructional video describing proper walking technique particularly up flights of stairs for patients to do at home. This will be shown at preoperative surgical clinic and will be available for access at home from patient's cell phones. The video is currently in production at BMC. Additionally, text reminders will be sent daily to remind patients to walk at home.

Intervention Type: OTHER

Moderate aerobic exercise

Participants will be encouraged to compete 140-150 minutes of moderate aerobic exercise per week- achieved by two walking sessions per day 10-11 minutes in length (realistic/achievable goal)

Intervention Type: BEHAVIORAL

Text messages

Text reminders will be sent daily to remind patients to walk at home.

Intervention Type: OTHER

Pedometer

Participants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients within general surgery, colorectal, and surgical oncology departments at Boston Medical Center.
• English or Spanish speaking
• Able to ambulate without cane, walker, wheelchair
• Surgery scheduled within 4-8 weeks
• Must have cell phone with internet access and text message capabilities
• JH-HLM score of 6

Exclusion Criteria

• Limited/non readers (less than 5th grade reading level), assessed via comprehension of consent materials

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Spence, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Anesthesiology Department

Locations

Boston Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Spence, MD

Role: CONTACT

Nicole.Spence@bmc.org

617-638-6950

Vaibhav Gupta, BA

Role: CONTACT

vgupta21@bu.edu

617-638-6950

Facility Contacts

Nicole Spence, MD

Role: primary

Other Identifiers

H-42768

Identifier Type: -

Identifier Source: org_study_id